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Influenza Vaccine Research

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Influenza A and B viruses are responsible for causing influenza. It is an acute respiratory illness that occurs every year mainly during fall and winter (from late November through March).1 Therefore, CDC recommends to vaccinate everyone 6 months and older with influenza vaccine every year. Children aged 6 months – 4 years, adults 50 years and over, health care professionals, immunosuppressed personnel, American Indians/ Alaska natives, extremely obese patients (BMI ≥ 40) and pregnant women should be prioritized to receive influenza vaccines in case of limited vaccine supply.2 Among adults, people over 65 years have more chances of complications, hospitalizations and death from influenza vaccine as most of them have some chronic diseases which …show more content…

It was a randomized, double-blinded, phase IIIb-IV, active controlled trial that was carried out in USA and Canada to compare the effectiveness of high dose influenza vaccine (60 µg of hemagglutinin per strain) versus standard dose vaccine (15 µg of hemagglutinin per strain). Medically stable patients who are 65 years and over were included in the study. Participants with life threatening reaction to vaccines, history of Guillain-Barre syndrome, bleeding disorders, dementia, or if they received the flu vaccine within 6 months, were excluded from the study. The study was carried out for 2 years during flu season and each year participants were randomly assigned to receive 1:1 ratio of either the high dose (IIV3-HD) or standard dose (IIV3-SD) of influenza vaccine. Participants were contacted two times a week or at least once weekly by a call center between Jan to April. Participants reported to their specific site if they have any respiratory symptoms. The primary end point of the trial was the occurrence of influenza at least after 14 days from vaccinations. The trial also assessed effectiveness, immunogenicity and serious adverse events. A total of 30,000 participants were needed to meet the 80% power. In total, 31,989 participants were enrolled in the trial and so the study met power. Two sets of analysis were used in the trial: 1) Intention-to-treat analysis and 2) per protocol analysis. All 31,983 participants who received vaccines were included in intention-to-treat analysis and 31,803 participants were included in per protocol analysis. In intention-to-treat analysis, 228 participants (1.4%) in IIV3-HD group had influenza as compared to 301 participants (1.9%) in IIV3-SD group (relative efficacy, 24.2%, 95 % CI, 9.7-36.5). Throughout the trial at least one serious adverse event

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